Translated with AI
On October 23, 2025, the Spanish Royal Decree No. 942/2025 was published in the Boletín Oficial del Estado (BOE), completing the alignment of Spanish national legislation with the European IVDR (EU) 2017/746 Regulation on In Vitro Diagnostic Medical Devices. The Decree entered into force the day after its publication, on October 24, 2025.
With the issuance of Decree 942/2025, Spain strengthens its existing regulatory framework, ensuring that internal practices and the placing of IVD devices on the market are fully aligned with European requirements. The Decree also adds some specific national requirements to the IVDR Regulation.
The key points are detailed below.
Increased Obligations for “In-House” IVD Devices
The Decree establishes specific requirements for “In-House” IVDs – devices manufactured and used within the same healthcare facility (such as Clinical Laboratories) – equating them from a regulatory perspective to IVD manufacturers (Article 7). The goal is to subject IVD devices not covered by external certification to the highest quality standards:
- Mandatory ISO 15189: centers must obtain accreditation according to the international standard ISO 15189 (Quality and competence of medical laboratories). For the first time, ISO 15189 accreditation is not only recommended but becomes mandatory (legally binding) and required for those Centers that produce and use IVDs within their own healthcare facility.
Staggered deadlines are set based on the risk class of the device used:
- 2027: obligation applies to Class D (highest risk).
- 2032: obligation applies to Classes A/B (lowest risk).
This requirement is specifically linked to the provision of in vitro diagnostic services and the manufacture of devices for internal use, ensuring that even IVDs not certified by third parties (Notified Bodies) are subjected to a rigorous quality management system.
- Registration and Person Responsible Obligations: the obligation to designate a Person Responsible for Regulatory Compliance (PRRC), already required by the IVDR (EU) 2017/745 Regulation for medical device manufacturers, is extended and formalized by the Royal Decree to also cover laboratories that manufacture In-House devices.
These centers, now considered manufacturers for regulatory purposes, must notify the start of their manufacturing activity to the AEMPS (Spanish Agency for Medicines and Health Products) and formally appoint a Person Responsible for compliance with the established requirements.
Stricter Regulation for Genetic Testing
To protect the health and rights of patients, the Royal Decree introduces specific measures for genetic tests:
- Informed Consent: rules are imposed to ensure that, before undergoing a genetic test, the patient receives clear and complete information for ethical and legal reasons, covering the test’s purpose, its irreversibility, and its long-term impact (e.g., results may have significant consequences on reproductive choices, job opportunities, or access to insurance).
- Mandatory Genetic Counseling: centers offering genetic tests are now obligated to provide qualified genetic counseling services to patients. Article 34.2 specifies that centers must ensure the patient receives adequate genetic counseling before and after the communication of the result.
National Registration Obligation for Economic Operators
To ensure traceability, pending the full operability of EUDAMED, the Decree mandates the registration in the Marketing Register managed by the AEMPS for Importers and Distributors, in addition to manufacturers. This national registration is essential for legally placing products on the Iberian market.
👉 With its strategic and regulatory consulting services, Thema can accompany Medical Devices and in vitro diagnostic Medical Devices into the Spanish market in full compliance, ensuring that the quality management systems of importers, foreign manufacturers, and in-house manufacturers are fully compliant with the requirements.
SOURCE: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2025-21298
